Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Federico II University | OTHER |
| University of Agriculture Science, Uppsala, Sweden | UNKNOWN |
Not provided
Not provided
Not provided
Not provided
the aim of this study is to evaluate whether a Mediterranean diet rich in pasta and other starchy foods with a (Low-GI), as compared with a similar Mediterranean diet containing very little pasta and based on starchy foods with a (Hi-GI) is able to reduce insulin and glucose concentrations during a prolonged test study meal.
The overall aim of this study is to evaluate whether a Mediterranean diet rich in pasta and other starchy foods with a low glycemic response (Low-GI), as compared with a similar Mediterranean diet containing very little pasta and based on starchy foods with a high glycemic response (Hi-GI) is able to reduce insulin and glucose concentrations during a prolonged test study meal.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| <55 (Low-GI group) | Experimental | intervention weeks 1-12 the subjects in each group will be counseled to follow their weight maintaining assigned diet using a combination of prescribed menus (breakfast, lunch, and snack eating occasions) and an item specific version of the Pasta Recipe Builder (dinner). The two group-specific diet plans will mostly contain the same foods and beverages typically included in Mediterranean-style diets, except for substitutions of major sources of carbohydrate in their meals:Low-GI - pasta, barley, parboiled rice, legumes. |
|
| >70 (Hi-GI group). | Experimental | intervention weeks 1-12 the subjects in each group will be counseled to follow their weight maintaining assigned diet using a combination of prescribed menus (breakfast, lunch, and snack eating occasions) and an item specific version of the Pasta Recipe Builder (dinner). The two group-specific diet plans will mostly contain the same foods and beverages typically included in Mediterranean-style diets, except for substitutions of major sources of carbohydrate in their meals: Hi-GI - rice, potato, |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hi GI | Other | subjects will consume the same quantities of metabolizable CHOs (270 g/d) with 135 g of CHOs assigned to the GI intervention foods. The 135 g of CHOs will be distributed as 35 g GI breakfast product, 40 g GI lunch product, and 60 g GI dinner product. Assuming an average 2400 kcal/d total energy requirement among subjects, the 270 g/d metabolizable CHO equates to 40% of total energy intake (1080 kcal/d). One-half of daily CHO intake (135 g/d) will be the same between the Hi-GI and Low-GI groups, including CHOs in fruits, vegetables, and other foods that all subjects will consume. The other one-half of daily CHO intake (135 g) will be different between the Low-GI and Hi-GI groups. Specifically, the GI values of these foods will either be <55 (Low-GI group) or >70 (Hi-GI group). |
| Measure | Description | Time Frame |
|---|---|---|
| The effects of Low-GI and Hi-GI diets | All subjects will consume the same quantities of metabolizable carbohydrate (270 g/d) with 135 g of carbohydrates assigned to the GI intervention foods. The 135 g of carbohydrates will be distributed as 35 g GI breakfast product, 40 g GI lunch product, and 60 g GI dinner product. Fiber is set as 35 g/d for both intervention groups. Assuming an average 2400 kcal/d total energy requirement among subjects, the 270 g/d metabolizable CHO equates to 40% of total energy intake (1080 kcal/d). One-half of daily CHO intake (135 g/d) will be the same between the Hi-GI and Low-GI groups, including CHOs in fruits, vegetables, and other foods that all subjects will consume. The other one-half of daily CHO intake (135 g) will be different between the Low-GI and Hi-GI groups. Specifically, the GI values of these foods will either be <55 (Low-GI group) or >70 (Hi-GI group). | 15weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Insulin Sensitivity | Measures of Insulin Sensitivity will include fasting serum lipid-lipoprotein profile, plasma fasting and postprandial glucose, insulin, CRP, C-peptide, fasting HbA1c, 24-hour interstitial continuous glucose monitoring (Medtronic ipro2 Professional CGM device (Northridge, CA). | 15 weeks |
Not provided
Inclusion Criteria:
• BMI 25-37 kg/m2 with a waist circumference > 102 cm (males) or > 88 cm (females) and one additional feature of Metabolic Syndrome according to ATPIII [1], including blood pressure > 130/85 or treatment, fasting plasma glucose >100mg/dL, fasting triglycerides >150 mg/dL, HDL cholesterol < 40 mg/dL (males) or 50 mg/dL (females),
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Gabriele Riccardi (riccardi@unina.it), M.D | Federico II University | Principal Investigator |
| Rikard Landberg (rikard.landberg@slu.), Ph.D | Uppsala University, Uppsala, Sweden | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Purdue University | West Lafayette | Indiana | 47907 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39615596 | Derived | Giosue A, Skantze V, Hjorth T, Hjort A, Brunius C, Giacco R, Costabile G, Vitale M, Wallman M, Jirstrand M, Bergia R, Campbell WW, Riccardi G, Landberg R. Association of the glucose patterns after a single nonstandardized meal with the habitual diet composition and features of the daily glucose profile in individuals without diabetes. Am J Clin Nutr. 2025 Feb;121(2):246-255. doi: 10.1016/j.ajcnut.2024.11.028. Epub 2024 Nov 28. | |
| 39004223 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D007333 | Insulin Resistance |
| ID | Term |
|---|---|
| D006946 | Hyperinsulinism |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
Not provided
Not provided
block randomized, parallel, controlled,
Not provided
Not provided
Not provided
|
|
| Derived |
| Hjort A, Bergia RE, Vitale M, Costabile G, Giacco R, Riccardi G, Campbell WW, Landberg R. Low- versus High-Glycemic Index Mediterranean-Style Eating Patterns Improved Some Domains of Health-Related Quality of Life but Not Sleep in Adults at Risk for Type 2 Diabetes: The MEDGICarb Randomized Controlled Trial. J Nutr. 2024 Sep;154(9):2743-2751. doi: 10.1016/j.tjnut.2024.07.005. Epub 2024 Jul 14. |
| 38267533 | Derived | Costabile G, Bergia RE, Vitale M, Hjorth T, Campbell W, Landberg R, Riccardi G, Giacco R. Effects on cardiovascular risk factors of a low- vs high-glycemic index Mediterranean diet in high cardiometabolic risk individuals: the MEDGI-Carb study. Eur J Clin Nutr. 2024 May;78(5):384-390. doi: 10.1038/s41430-024-01406-y. Epub 2024 Jan 24. |
| 37651979 | Derived | Vitale M, Costabile G, Bergia RE, Hjorth T, Campbell WW, Landberg R, Riccardi G, Giacco R. The effects of Mediterranean diets with low or high glycemic index on plasma glucose and insulin profiles are different in adult men and women: Data from MEDGI-Carb randomized clinical trial. Clin Nutr. 2023 Oct;42(10):2022-2028. doi: 10.1016/j.clnu.2023.08.016. Epub 2023 Aug 25. |
| 32885091 | Derived | Bergia RE 3rd, Biskup I, Giacco R, Costabile G, Gray S, Wright A, Vitale M, Campbell WW, Landberg R, Riccardi G. The MEDGICarb-Study: Design of a multi-center randomized controlled trial to determine the differential health-promoting effects of low- and high-glycemic index Mediterranean-style eating patterns. Contemp Clin Trials Commun. 2020 Aug 13;19:100640. doi: 10.1016/j.conctc.2020.100640. eCollection 2020 Sep. |